Refractory Acute Leukemia Clinical Trial
Official title:
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).
Primary Objectives - To determine the safety, tolerability, and recommended Phase II dose (RP2D) of ziftomenib in combination with venetoclax and azacitidine for pediatric participants with acute leukemias with KMT2A-r, NPM1-m or NUP98-r. Secondary Objectives - To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (CRi), morphological leukemia-free state (MLFS) and partial remission (PR), overall survival (OS), event-free survival (EFS) and duration of response (DOR) of pediatric participants treated with this combination. Exploratory Objective - To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01701375 -
A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia
|
Phase 1 | |
| Active, not recruiting |
NCT05029141 -
New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 2 | |
| Active, not recruiting |
NCT03834961 -
Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia
|
Phase 2 | |
| Recruiting |
NCT00984412 -
Allo-Allo Tandem Bone Marrow Transplant (BMT)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04681105 -
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
|
Phase 1 | |
| Completed |
NCT03735875 -
Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Completed |
NCT00410423 -
Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06466395 -
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
|
Phase 1 |